A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus in Subjects Undergoing Elective Bowel Resection
Overview
- Phase
- Phase 2
- Intervention
- LB1148
- Conditions
- Ileus
- Sponsor
- Newsoara Biopharma Co., Ltd.
- Enrollment
- 131
- Locations
- 6
- Primary Endpoint
- Time to reach GI-2
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of return of gastrointestinal function and decrease Post-Operative Ileus in subjects undergoing elective bowel resection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Scheduled to undergo an elective (non-emergent) bowel resection with or without a planned stoma via laparotomy or minimally invasive technique. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elected indication.
- •Has been informed of the nature of the study (either the subject or their legal representative), agrees to its provisions, and has provided written informed consent.
Exclusion Criteria
- •\<18 or \>80 years of age.
- •Requires emergency bowel surgery.
- •Has had 1 or more abdominal surgeries, excluding the current, for inflammatory bowel disease, including, but not limited to, inflammatory bowel disease (IBD), Crohn's Disease, or ulcerative colitis.
- •Note: This does not apply to previous surgery such as hernia repair unrelated to IBD.
- •American Society of Anesthesiologists (ASA) Class 4 or
- •Insulin dependent diabetes mellitus.
- •Known inability to take the study drug orally (i.e. complete small bowel obstruction).
- •Has contraindications or potential risk factors to taking tranexamic acid (TXA). These include subjects with:
- •Known sensitivity to tranexamic acid (TXA);
- •Recent craniotomy (past 30 days);
Arms & Interventions
LB1148
active
Intervention: LB1148
Placebo
placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Time to reach GI-2
Time Frame: within 14 days after surgery
• GI-2 is defined as the toleration of solid food and first bowel movement. * Ability to tolerate a solid oral diet is defined as the time from the end of surgery (the time of last skin staple or suture is placed by surgeon) to the time a patient finishes first solid meal that requires chewing and no significant nausea or vomiting for 4 hours after solid meal). * First bowel movement is defined as the time from the end of surgery to the first passage of stool.
Secondary Outcomes
- Nausea Verbal Rating Scoring Scale(within 14 days after surgery)
- Number of days in the hospital(within 14 days after surgery)
- Time to reach GI-3(within 14 days after surgery)